This invention is in the technical field of medical instruments and involves fluid handling, light treatment for internal healing, antimicrobial features and vision; and it is exemplified by catheters for urology. As one example of applications, a catheter according to the invention may be utilized during and after radical prostatectomy or urethral reconstruction to promote faster healing and improve general outcome of the procedure. As another example of applications, a catheter according to the invention may be in-dwelling for an extended time in patients while providing reduced risk for infections that may otherwise arise with long term use. Additional applications of the invention include other medical fields that utilize catheters, endoscopes or similar instruments internally in the patient.
The use of catheters inside the body is necessary for several medical conditions and procedures—with associated risks. As an example, it has been suggested that urinary tract infections today contribute to approximately 40% of hospital acquired infections. The infection risk accelerates with longer in-dwelling time. This is a significant issue for the patient long term health and quality of life, and a non-trivial part of the problematic national healthcare cost situation. Various methods have been suggested for catheters to achieve reduced infection risk. This includes for instance, improved antimicrobial coatings, materials with low affinity for harboring foreign matter, agents applied at time of use on the catheter exterior, as well as catheter insertion shields and protection methods.
But despite all this available catheter technology, the current rate of urinary tract infections related to urology procedures is still a major problem. One option is to apply higher doses, more potent or new formula antimicrobial agents. This may not be a viable solution for the future due to breeding of resistant microbial strains. General concerns in all methods that apply antimicrobial agents onto catheters include quality control of the initial application for adequate coverage, and the potential risk for agent removal or degradation by extended time of use, or by catheter to patient motion. The effectiveness of the antimicrobial application is therefore uncertain for long term use. The exterior of the catheter may be touched by the patient's hands or nearby body parts which may harbor bacteria. As an example, the female anatomy introduces a special risk by the proximity between the urethral meatus to the vaginal vault and also the anus. There is additionally a risk of infection through the liquid carrying lumen internal of the catheter. Although the urine is generally sterile and flows away from the patient, bacteria may enter the urinary system through a catheter lumen due to position changes and of catheter and patient and gravity, or by slow migration and liquid turbulence.
One example of a major urology procedure is radical prostatectomy. This has recently been improved with advanced instruments for robot assisted laparoscopic surgery. As part of this procedure, the severed urethra has to undergo anastomosis to the urethral stump at the bladder. It is essential that the healing process for the urethra is starting under favorable conditions and as early as possible, for faster recovery, patient comfort and reduced risk for scars or strictures as added complications later on. Furthermore, the urethra/bladder must be significantly stretched in length for anastomosis after the prostate removal and can not be stretched any further, so a repeat operation is not viable. This implies that doing the anastomosis procedure right the first time is essential. Particular problems to be solved include better visualization and control of the anastomosis for the operator, and methods to achieve a head start of the healing process at an early stage for quicker recovery and less scar tissue. This can also assist in reducing the length of time for the patient to stay catheterized as part of post-surgery. The catherization is currently approximately 7-14 days depending on healing progress and surgery quality, and such a lengthy in-dwelling period also may increase risk for urinary tract infections related to the catheter.
Catheters that provide integrated vision devices in addition to liquid handling have been introduced. A real time view of the interior of body lumina and cavities during catherization significantly reduces the risk for mis-catherization. To implement this for urology procedures was a particular challenge for the small diameter, highly flexible catheters that are demanded for urology. It has recently resulted in successful commercial products. Such vision catheters are described in U.S. Pat. Nos. 6,994,667 and 6,599,237, and also in PCT patent application PCT/US12/40877, filed Jun. 5, 2012, all of which are hereby incorporated by reference.
Due to the recently improved understanding of light interaction with living cells, low level light therapy in the medical field has received new attention. There is an increasing use of low level light radiation as a means of sterilizing, antimicrobial, stimulating or healing function in medical devices and procedures. Such applications were first focused on external treatment but are now also finding use inside body cavities, lumina and openings created by surgical procedures. Applications of light energy in urology have so far been limited to diagnostics, high energy treatment for localized heating or by killing undesired cells by vaporization, or light for photodynamic therapy by activating drugs or other agents at desired location in the patient.
For applications like urology, the cross-sectional area of catheters is limited due to the confines of the urethra. This has been a barrier in making a catheter with light treatment functionality as well as liquid handling. It is obvious that the problem is even more difficult to solve to include both vision and light treatment capability to a small size fluid handling catheter.
Another limiting factor in catheters borne by a patient for extended time is the convenience and comfort for the patient to move around and to perform normal personal duties. Catheters that are long term in-dwelling should ideally be light weight, flexible, compact and have no need for cables to a stationary apparatus.
Although the examples recited in this invention are primarily related to catheterization in urology, there are similar needs in several other medical fields where the invention can assist to solve current problems. Examples of such fields of use include but are not limited to: endotrachial, pulmonology, gynecology, proctology, cardiology, gastric including oral or nasogastric intubation, and vascular surgery or treatment.
It is additionally noted that the term “catheter with vision” may be overlapping in function with terms similar to “endoscope including fluid handling.” This invention may therefore also be applied for problem solving in applicable fields of endoscopy with fluid handling. Specialty endoscopy applications for the invention may include, but are not limited to, laparoscopy, bronchoscopy, gynoscopy, rhinoscopy, arthroscopy, enteroscopy and colonoscopy.
It is the goal of this invention to provide a catheter platform system that overcomes the mentioned difficulties of prior art. In addition it has low cost, it is disposable and can be adapted to both male and female patients and tailored for specific needs.